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Sunday, December 6, 2015
ORLANDO, Fla.--(BUSINESS WIRE)--Adaptive Biotechnologies, the leader in combining next-generation
sequencing (NGS) and expert bioinformatics to profile T-cell and B-cell
receptors of the adaptive immune system, and collaborators from the
Dana-Farber Cancer Institute and University Hospital in Toulouse, France
will today present data showing that Adaptive’s NGS-based MRD assessment
method (available for clinical use through Adaptive’s CLIA-certified
laboratory as the clonoSEQ® Process) sensitively detects
minute traces of myeloma in clinical trial patients and predicts
outcomes better than flow cytometry, supporting the use of the technique
as a surrogate endpoint.
“With current intensive approaches to the treatment of myeloma, complete
response rates are regularly achieved in the range of 50-70 percent,
making conventional evaluations of response less helpful in clinical
trials,” said Nikhil Munshi, M.D., Director of Basic and Correlative
Science, Jerome Lipper Multiple Myeloma Center, Dana-Farber Cancer
Institute, and a lead investigator on the study being presented at the 57th
Annual Meeting of the American Society of Hematology Meeting in Orlando,
FL. Buy Lasix (Furosemide) with no prescription “More sensitive tools for evaluating response will be necessary
moving forward in clinical trial development, and in this study we
showed that NGS-based minimal residual disease measurement is an
attractive choice.”
The IFM/DFCI 2009 trial was designed to determine whether in the era of
novel drugs, high dose therapy followed by autologous transplant is
still necessary in the initial management of multiple myeloma in younger
patients (<66 years old). About Microzide (Hydrochlorothiazide) without Rx Bone marrow samples taken before maintenance
therapy were analyzed for MRD using Adaptive’s technology in a total 246
patients. About Gasex () with no Rx Samples taken after maintenance were analyzed for 178 patients.
There was a significant difference in the number patients who lived for
three years without their disease getting worse [3-year progression-free
survival (PFS)] when comparing MRD-negative and positive patients
(sensitivity cutoff of one myeloma cell per one million white blood
cells) when MRD was measured at pre-maintenance (83%, vs. Buy Ipratropium with no prescription 53%, p<0.0001)
and post-maintenance (90% vs. Buspar (Buspirone) 59%, p<0.0001). Buy Immune Supplements online Importantly, the ability
of MRD status to predict outcome (3-year PFS) held when analysis was
restricted to just those patients who achieved a complete response as
determined by conventional criteria (Pre-maintenance: 87% vs. http://pharmaceuticaljournal.wordpress.com 63%,
p=0.0075; post-maintenance: 92% vs. 64%, p<0.0001).
The importance of using the most sensitive technique possible for MRD
detection when evaluating response as a possible surrogate for outcome
was shown by an analysis comparing Adaptive’s NGS-based MRD test to
seven-color flow cytometry with maximum sensitivity of one myeloma cell
per 10,000 white blood cells. Of 163 patients MRD-negative by flow
cytometry, 84 (51%) patients were positive using Adaptive’s NGS-based
test. Furthermore, there was a significant difference in 3-year PFS
between flow-negative/NGS-MRD-negative and
flow-negative/NGS-MRD-positive patients (Pre-maintenance: 86% vs. 66%,
p=0.0002; Post-maintenance: 91% vs. 65%, p=0.0006).
“MRD-negativity is quickly replacing conventional complete response as
the endpoint of choice when evaluating new medicines for myeloma in
clinical trials,” said Tom Willis, Ph.D., Senior Vice President and
General Manager, Diagnostic Products, Adaptive Biotechnologies.
“Multiple pharmaceutical companies are now using Adaptive’s NGS-based
MRD assessment method in their clinical trials due to its superiority
over flow cytometry in terms of sensitivity, standardization and
prediction of outcomes.”
Abstract
No. 191: Evaluation of Minimal Residual Disease (MRD) by Next Generation
Sequencing (NGS) is Highly Predictive of Progression Free Survival in
the IFM/DFCI 2009 Trial
Session: Myeloma: Therapy, excluding Transplantation: Amyloidosis and
Related Plasma Cell Disorders
Sunday, December 6, 2015, 8:30 a.m. ET
Tangerine 2 (WF2 | Orange County Convention Center)
About Minimal Residual Disease
Minimal residual disease (MRD) refers to cancer cells that may remain in
the body of a person with lymphoid cancer after treatment. These cells
are present at levels undetectable by traditional microscopic
examination (also called morphologic examination) of blood, bone marrow
or a lymph node biopsy. Sensitive molecular technologies, such as the
next-generation sequencing utilized by the Adaptive Biotechnologies
clonoSEQ MRD Test, are needed for reliable detection of very low levels
of MRD.
About the clonoSEQ® Process
The Adaptive Biotechnologies clonoSEQ Process enables physicians to
utilize sequencing-based minimal residual disease (MRD) detection as an
aid to clinical decision making for patients with lymphoid cancers
(blood cancers). With its ability to detect cancer cells at a level as
low as one per one million white blood cells, the clonoSEQ MRD Test is
one to two orders of magnitude more sensitive than other methods of MRD
detection, such as ASO-PCR and flow cytometry. The clonoSEQ Process was
previously marketed as the ClonoSIGHT™ process by Sequenta, Inc., which
was acquired by Adaptive Biotechnologies in January 2015.
MRD detection and quantification using the clonoSEQ Process involves two
steps that are easily integrated into patient care. In the first step,
the clonoSEQ ID Test, cancer cell DNA sequences are identified in a
diagnostic sample. In the second step, the clonoSEQ MRD Test, follow-up
samples are screened for the previously identified sequences in order to
detect residual disease. ClonoSEQ test results are generated in seven
days using the company’s CLIA-certified, CAP-accredited laboratory.
These results are provided to the ordering physician in a simple,
actionable report that shows a patient’s MRD status and level, as well
as MRD trends over time via a secure online portal.
About Adaptive Biotechnologies
Adaptive Biotechnologies is the pioneer and leader in combining
high-throughput sequencing and expert bioinformatics to profile T-cell
and B-cell receptors. Adaptive is bringing the accuracy and sensitivity
of its immunosequencing platform into laboratories around the world to
drive groundbreaking research in cancer and other immune-mediated
diseases. Adaptive also translates immunosequencing discoveries into
clinical diagnostics and therapeutic development to improve patient care.
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